Current State of Funded National Cancer Institute Grants That Include Economic Analyses.

BACKGROUND: Health economics research is an integral part of the transdisciplinary research supported by the National Cancer Institute (NCI). To better understand NCI activities in this area, we conducted a portfolio analysis of funded NCI grants including health economics research. METHODS: We examined all competitive grants funded by NCI from fiscal years 2015 to 2020 that included economic analyses or outcomes. Grant titles, abstracts, and specific aims were independently reviewed by 2 study team members; content of included grants was then coded for analysis. RESULTS: A total 212 grants were identified from searches; 146 of these included economic analyses and were included in the portfolio analysis. These 146 grants represent approximately 0.9% of all NCI competitively funded grants awarded 2015-2020. Of these grants, 100 were R01 awards, representing approximately 2.4% of all NCI R01 grants funded 2015-2020. The most common study type was interventional randomized controlled-trial, followed by simulation or model. Screening and prevention were the most frequent grant cancer continuum topic; survivorship was included in only 16 grants (11.0%). Cost-effectiveness analysis was the most frequently listed economic outcome (97 grants, 66.4%), whereas policy impact (20 grants, 13.7%) and financial hardship (15 grants, 10.3%) were less-frequently included economic outcomes. However, economic outcomes differed by cancer control continuum topic, with financial hardship being included in a greater proportion of treatment and survivorship grants. CONCLUSIONS: Although relatively small, the NCI portfolio of funded grants including economic analyses is diverse, covering a range of cancer types, methods, and economic outcomes, and increasing over time.

Assessing Electronic Nicotine Delivery Systems Use at NCI-Designated Cancer Centers in the Cancer Moonshot-funded Cancer Center Cessation Initiative.

Assessing tobacco product use and delivering tobacco dependence treatment is an essential part of cancer care; however, little is known about electronic nicotine delivery systems (ENDS) or e-cigarette use assessment in cancer treatment settings. Given the importance of tailoring tobacco treatment, it is critical to understand how ENDS use is assessed in the electronic health record (EHR) in cancer care settings. Two questionnaires were completed by tobacco treatment program leads at 42 NCI-Designated Cancer Centers in the Cancer Center Cessation Initiative (January 1 to June 30 and July 1 to December 31, 2019). Items assessed how often smoking status and ENDS use were recorded in the EHR. An open-ended item recorded the text and response categories of each center's ENDS assessment question. All 42 centers assessed smoking status at both time periods. Twenty-five centers (59.5%) assessed ENDS use in the first half of 2019, increasing to 30 (71.4%) in the last half of 2019. By the end of 2019, 17 centers assessed smoking status at every patient visit while six assessed ENDS use at every visit. A checkbox/drop-down menu rather than scripted text was used at 30 centers (73.2%) for assessing smoking status and at 18 centers (42.9%) for assessing ENDS use. Our findings underscore the gap in systematic ENDS use screening in cancer treatment settings. Requiring ENDS use measures in the EHR as part of quality measures and providing scripted text scripts to providers may increase rates of ENDS use assessment at more cancer centers. PREVENTION RELEVANCE: This study identifies a gap in the systematic assessment of ENDS use among patients seen at 42 NCI-Designated cancer centers. Requiring the systematic assessment of both ENDS use and use of other tobacco products can inform evidence-based treatment of tobacco dependence and lead to improved cancer treatment outcomes.

Congress Approves Increase in Cancer Funding.

The federal spending bill enacted by the U.S. Congress in December for fiscal year 2021 totals $1.4 trillion, plus another $900 billion in emergency COVID-19 relief funding. The $1.4 trillion includes budget increases for the NIH, NCI, and FDA that help the agencies keep pace with inflation. Research advocates say more than $10 billion in emergency supplemental funds for the NIH is urgently needed to support medical research affected by the COVID-19 pandemic.

Expenditures among young adults with acute lymphoblastic leukemia by site of care.

BACKGROUND: Individuals diagnosed with acute lymphoblastic leukemia (ALL) between the ages of 22 and 39 years experience worse outcomes than those diagnosed when they are 21 years old or younger. Treatment at National Cancer Institute-designated Comprehensive Cancer Centers (CCC) mitigates these disparities but may be associated with higher expenditures. METHODS: Using deidentified administrative claims data (OptumLabs Data Warehouse), the cancer-related expenditures were examined among patients with ALL diagnosed between 2001 and 2014. Multivariable generalized linear model with log-link modeled average monthly health-plan-paid (HPP) expenditures and amount owed by the patient (out-of-pocket [OOP]). Cost ratios were used to calculate excess expenditures (CCC vs non-CCC). Incidence rate ratios (IRRs) compared CCC and non-CCC monthly visit rates. Models adjusted for sociodemographics, comorbidities, adverse events, and months enrolled. RESULTS: Clinical and sociodemographic characteristics were comparable between CCC (n = 160) and non-CCC (n = 139) patients. Higher monthly outpatient expenditures in CCC patients ($15,792 vs $6404; P < .001) were driven by outpatient hospital HPP expenditures. Monthly visit rates and per visit expenditures for nonchemotherapy visits (IRR = 1.6; P = .001; CCC = $8247, non-CCC = $1191) drove higher outpatient hospital expenditures among CCCs. Monthly OOP expenditures were higher at CCCs for outpatient care (P = .02). Inpatient HPP expenditures were significantly higher at CCCs ($25,918 vs $13,881; ꞵ = 0.9; P < .001) before accounting for adverse events but were no longer significant after adjusting for adverse events (ꞵ = 0.4; P = .1). Hospitalizations and length of stay were comparable. CONCLUSIONS: Young adults with ALL at CCCs have higher expenditures, likely reflecting differences in facility structure, billing practices, and comprehensive patient care. It would be reasonable to consider CCCs comparable to the oncology care model and incentivize the framework to achieve superior outcomes and long-term cost savings. LAY SUMMARY: Health care expenditures in young adults (aged 22-39 years) with acute lymphoblastic leukemia (ALL) are higher among patients at National Cancer Institute-designated Comprehensive Cancer Centers (CCC) than those at non-CCCs. The CCC/non-CCC differences are significant among outpatient expenditures, which are driven by higher rates of outpatient hospital visits and outpatient hospital expenditures per visit at CCCs. Higher expenditures and visit rates of outpatient hospital visits among CCCs may also reflect how facility structure and billing patterns influence spending or comprehensive care. Young adults at CCCs face higher inpatient HPP expenditures; these are driven by serious adverse events.

Economic Evaluations in National Cancer Institute-Sponsored Network Cancer Clinical Trials.

OBJECTIVES: Amid a rapid increase in cancer care costs, we examined the extent to which economic evaluations (EEs) were conducted for new treatments evaluated in clinical trials at SWOG, a large National Cancer Institute-sponsored cancer research network. METHODS: We investigated phase III cancer treatment clinical trials activated from 1980 onward with primary articles reporting the protocol-designated endpoints published in scientific journals by 2017. Using PubMed, Web of Science, and EconLit, we searched for EEs using trial name, cancer type, information on the comparison arms, and refined keywords for EE designs. We reported the overall proportion of trials with associated EEs and trends of this proportion over time. We synthesized and analyzed information on funding sources, health outcomes, and sources of quality-of-life and cost data from the EEs. RESULTS: Among 182 examined trials, 15 EEs were associated with 13 (7.1%) trials. Among the EEs, almost half (7 of 15) were either unfunded or did not report funding information, whereas nearly half (7 of 15) were funded by pharmaceutical companies and 2 (2 of 15, 13.3%) were supported by federal funding. All EEs reported a healthcare payer perspective. The proportion of trials with an associated EE increased from 1980 to 1989 and 2000 to 2009, but never exceeded 11%. Sources for cost and quality-of-life data for the EEs primarily came from outside the clinical trials. CONCLUSIONS: Few economic studies of treatments evaluated in National Cancer Institute-sponsored clinical trials have been conducted. Policymakers, payers, and patients lack economic evidence to consider newly evaluated cancer treatments, despite an urgent need to control healthcare costs.

NCI's Work to Advance Cancer Research while Responding to the COVID-19 Pandemic.

During the COVID-19 pandemic, the National Cancer Institute (NCI) is bringing to bear its considerable expertise and capabilities to understand, treat, and prevent the disease. While responding to the pandemic, NCI's priority remains the advancement of cancer research. NCI has implemented many flexibilities for grantees and trainees.

COVID-19 Hits Cancer Research Funding.

As the COVID-19 pandemic stretches on, investigators are becoming increasingly concerned about longer-term effects on grants and funding for cancer research. Institutions and philanthropic organizations are especially likely to be hit hard by the economic crisis, with effects that will be particularly acute for early-career investigators.

The National MDS Natural History Study: design of an integrated data and sample biorepository to promote research studies in myelodysplastic syndromes.

Myelodysplastic syndromes (MDS), a spectrum of heterogeneous hematopoietic stem cell diseases, vary in clinical severity, response to therapy, and propensity toward progression to acute myeloid leukemia. These are acquired clonal disorders resulting from somatic mutations within the hematopoietic stem or progenitor cell population. Understanding the natural history and the risk of developing leukemia and other adverse outcomes is dependent on access to well-annotated biospecimens linked to robust clinical and molecular data. To facilitate the acquisition and distribution of MDS biospecimens to the wider scientific community and support scientific discovery in this disease, the National MDS Natural History study was initiated by the National Heart, Lung, and Blood Institute (NHLBI) and is being conducted in collaboration with community hospitals and academic medical centers supported by the National Cancer Institute (NCI). The study will recruit up to 2000 MDS patients or overlapping myeloproliferative neoplasms (MDS/MPN) and up to 500 cases of idiopathic cytopenia of undetermined significance (ICUS). The National MDS Natural History Study (NCT02775383) will offer the world's largest disease-focused tissue biobank linked to longitudinal clinical and molecular data in MDS. Here, we report on the study design features and describe the vanguard phase of 200 cases. The study assembles a comprehensive clinical database, quality of life results, laboratory data, histopathology slides and images, genetic information, hematopoietic and germline tissues representing high-quality biospecimens and data from diverse centers across the United States. These resources will be available to the scientific community for investigator-initiated research.

The Partnership for Accelerating Cancer Therapies.

As a part of the Cancer Moonshot, the National Cancer Institute, part of the National Institutes of Health, the Foundation for National Institutes of Health, the US Food and Drug Administration, and 12 pharmaceutical companies have formed a 5-year, $220 million precompetitive public-private research collaboration called the Partnership for Accelerating Cancer Therapies. A systematic cross-sector effort to identify and develop robust, standardized biomarkers and related clinical data, Partnership for Accelerating Cancer Therapies will support the selection and testing of promising immunotherapies for the treatment of cancer, with the goal of bringing effective therapy to more patients.

The NCI Physical Sciences - Oncology Network.

Nastaran Zahir is Associate Director of the Physical Sciences - Oncology Network in the Division of Cancer Biology at the National Cancer Institute. Dr. Zahir coordinates cross-cutting efforts to integrate physical sciences perspectives with cancer research by fostering transdisciplinary research collaborations, supporting education and outreach programs, and promoting resources for data sharing and biospecimen standards.

Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials.

PURPOSE: Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials. METHODS: We performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths. RESULTS: De-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (p < 0.001). Breast cancer patients had more clinical responses than non-BC patients (18.3% vs. 4.3%, respectively). Along with the higher rate of response, BC patients remained on phase I trials longer than non-BC patients with a median of 70 days while the latter were on trial for a median of 57 days. The overall rate of death related to the treatment drugs was 0.47%. CONCLUSIONS: Our data confirm our hypothesis that when compared to a general population of patients with cancer enrolled on phase I clinical trials, BC patients tend to derive clinical benefit from these therapies with similar toxicity profile. This evidence further supports enrollment of BC patients on phase I trials.

Making the Case for Investment in Rural Cancer Control: An Analysis of Rural Cancer Incidence, Mortality, and Funding Trends.

Estimates of those living in rural counties vary from 46.2 to 59 million, or 14% to 19% of the U.S. POPULATION: Rural communities face disadvantages compared with urban areas, including higher poverty, lower educational attainment, and lack of access to health services. We aimed to demonstrate rural-urban disparities in cancer and to examine NCI-funded cancer control grants focused on rural populations. Estimates of 5-year cancer incidence and mortality from 2009 to 2013 were generated for counties at each level of the rural-urban continuum and for metropolitan versus nonmetropolitan counties, for all cancers combined and several individual cancer types. We also examined the number and foci of rural cancer control grants funded by NCI from 2011 to 2016. Cancer incidence was 447 cases per 100,000 in metropolitan counties and 460 per 100,000 in nonmetropolitan counties (P < 0.001). Cancer mortality rates were 166 per 100,000 in metropolitan counties and 182 per 100,000 in nonmetropolitan counties (P < 0.001). Higher incidence and mortality in rural areas were observed for cervical, colorectal, kidney, lung, melanoma, and oropharyngeal cancers. There were 48 R- and 3 P-mechanism rural-focused grants funded from 2011 to 2016 (3% of 1,655). Further investment is needed to disentangle the effects of individual-level SES and area-level factors to understand observed effects of rurality on cancer. Cancer Epidemiol Biomarkers Prev; 26(7); 992-7. ©2017 AACR.

Congress OKs $2 Billion Boost for the NIH.

President Donald Trump last week signed a $1.1 trillion spending bill for fiscal year 2017, including a welcome $2 billion boost for the NIH that will support former Vice President Joe Biden's Cancer Moonshot initiative, among other priorities. However, researchers who rely heavily on NIH grant funding remain concerned about proposed cuts for 2018.

The National Cancer Institute R25 Cancer Education Grants Program: A Workshop Report.

Through the R25 Cancer Education Grants Program (CEGP), the National Cancer Institute (NCI) has been supporting the broad educational needs of the cancer research and cancer healthcare communities since 1974. NCI sponsored a workshop on September 13, 2016 in Bethesda, Maryland, with the objectives of sharing best practices in cancer education, communicating R25 CEGP programmatic information, and gathering ideas to strengthen the R25 CEGP to better meet the emerging needs in cancer education in the face of a rapidly changing landscape in cancer research and cancer care. With 53 leaders in cancer education in attendance, the workshop featured an overview of the R25 CEGP by NCI Program Staff, a showcase of several types of CEGP programs by current R25 grantees, and in-depth discussions on a broad range of questions critical for the continued success of the R25 CEGP. The workshop afforded an opportunity, for the first time, for cancer researchers and clinicians conducting different forms of cancer education activities to gather in one place as leaders of a community of increasing importance. The discussion resulted in a set of suggestions that will benefit the R25 CEGP and cancer education in general. There was a general consensus among the participants that bringing the cancer education community together is a significant achievement of the workshop that will have a long-lasting impact on cancer education.

Recent Trends in Oral Cavity Cancer Research Support in the United States.

The objectives were to characterize oral cavity cancer (OCC) funding from the National Institutes of Health (NIH) with a secondary aim of comparing NIH support provided to OCC and other malignancies. NIH awards supporting OCC inquiry from 2000 to 2014 were accessed from the NIH RePORTER database. These data were used to evaluate temporal trends and the role of human papilloma virus and to determine the academic training and professional profiles of the principal investigators. Comparison of 2014 funding levels with other malignancies was also performed, controlling for incidence. Overall funding totals decreased considerably after 2009. Funding administered through the National Institute of Dental and Craniofacial Research (NIDCR) was 6.5 times greater than dollars awarded by the National Cancer Institute in 2000. During the period evaluated, NIDCR support decreased in most years, while National Cancer Institute support increased and approached NIDCR funding levels. Funding for human papilloma virus-related projects gradually rose, from 3.4% of dollars in 2000 to 2004 to 6.2% from 2010 to 2014 ( P < 0.05). A majority of principal investigators had a PhD omnia solus (57%), and 13% possessed dual PhD/clinical degrees. Among clinicians with specialty training, otolaryngologists and oral/maxillofacial pathologists garnered the most funding. OCC had a 2014 funding:incidence ratio of $785, much lower than for other malignancies. There has been increased volatility in funding support in recent years possibly due to budget cuts and sequestration. The National Cancer Institute has played an increasingly important role in supporting OCC research, concomitant with decreasing NIDCR support. Our findings suggest that OCC is underfunded relative to other non-oral cavity malignancies, indicating a need to increase the focus on rectifying the disparity.

Interventions to improve the quality of life and survivorship of older adults with cancer: The funding landscape at NIH, ACS and PCORI.

Identifying knowledge gaps and research opportunities in cancer and aging research was the focus of a three-part conference series led by the Cancer and Aging Research Group from 2010 to 2015. The third meeting, featured representatives from the NIA, NCI, ACS and PCORI each of whom discussed research priorities and funding opportunities in cancer and aging at their respective agencies. This manuscript reports on the proceedings of that conference with a specific focus on funding priorities for interventions to improve the quality of life and survivorship of older adults with cancer. Helpful tips from each funder regarding writing a scientifically strong research proposal are presented.

Evolution of the "drivers" of translational cancer epidemiology: analysis of funded grants and the literature.

Concurrently with a workshop sponsored by the National Cancer Institute, we identified key "drivers" for accelerating cancer epidemiology across the translational research continuum in the 21st century: emerging technologies, a multilevel approach, knowledge integration, and team science. To map the evolution of these "drivers" and translational phases (T0-T4) in the past decade, we analyzed cancer epidemiology grants funded by the National Cancer Institute and published literature for 2000, 2005, and 2010. For each year, we evaluated the aims of all new/competing grants and abstracts of randomly selected PubMed articles. Compared with grants based on a single institution, consortium-based grants were more likely to incorporate contemporary technologies (P = 0.012), engage in multilevel analyses (P = 0.010), and incorporate elements of knowledge integration (P = 0.036). Approximately 74% of analyzed grants and publications involved discovery (T0) or characterization (T1) research, suggesting a need for more translational (T2-T4) research. Our evaluation indicated limited research in 1) a multilevel approach that incorporates molecular, individual, social, and environmental determinants and 2) knowledge integration that evaluates the robustness of scientific evidence. Cancer epidemiology is at the cusp of a paradigm shift, and the field will need to accelerate the pace of translating scientific discoveries in order to impart population health benefits. While multi-institutional and technology-driven collaboration is happening, concerted efforts to incorporate other key elements are warranted for the discipline to meet future challenges.